The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for D-10 Hemoglobin A1c.
Device ID | K031043 |
510k Number | K031043 |
Device Name: | D-10 HEMOGLOBIN A1C |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
Contact | Jackie Buckley |
Correspondent | Jackie Buckley BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
Product Code | LCP |
CFR Regulation Number | 864.7470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-01 |
Decision Date | 2003-08-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847817003417 | K031043 | 000 |
00847817003400 | K031043 | 000 |
00847817003356 | K031043 | 000 |
00847817003318 | K031043 | 000 |
00847817003301 | K031043 | 000 |
00847817003295 | K031043 | 000 |
00847817003288 | K031043 | 000 |
00847817003271 | K031043 | 000 |
00847817000089 | K031043 | 000 |